Previously we have described novel methods, systems, software programs, and manufacturing execution systems for validation, quality and risk assessment, and monitoring of pharmaceutical manufacturing processes. See, US2005/0251278 published 10 Nov. 2005; US2006/0276923 published 7 Dec. 2006; US2006/0271227 Published 30 Nov. 2006; US2007/0021856 Published 25 Jan. 2007; and US2007/0032897 Published 8 Feb. 2007. Additionally, we endeavor to further the state of the art using software and computer programming in the field of nanotechnology and supramolecular electronics.
Nanotechnology is a field of applied science and technology covering a broad range of topics. The main unifying theme is the control of matter on a scale smaller than one micrometer as well as the fabrication of devices on this same length scale. Worldwide research is currently being conducted in countess areas to discover new and useful areas where nanotechnology can be exploited commercially. The research involves potential utility in industrial applications, such as pharmaceutical manufacturing as well as other areas of medicine and bioenergy just to name a few.
Despite the apparent simplicity of this definition, nanotechnology actually encompasses diverse lines of inquiry. Nanotechnology cuts across many disciplines, including colloidal science, chemistry, applied physics, biology. It could variously be seen as an extension of existing sciences into the nanoscale, or as a recasting of existing sciences using a newer, more modern term.
Two main approaches are used in nanotechnology. One is a “bottom-up” approach where materials and devices are built from molecular components which assemble themselves chemically using principles of molecular recognition. The other being a “top-down” approach where nano-objects are constructed from larger entities without atomic-level control. Nanomaterials are materials having unique properties arising from their nanoscale dimensions. The use of nanoscale materials can also be used for bulk applications. In fact, most present commercial applications of nanotechnology are of this flavor.
Nanomaterials from a “top-down” design have certain scaling deficiencies which must be assessed. For example, A number of physical phenomena become noticeably pronounced as the size of the system decreases. These include statistical mechanical effects, as well as quantum mechanical effects, for example the “quantum size effect” where the electronic properties of solids are altered with great reductions in particle size. This effect does not come into play by going from macro to micro dimensions. However, it becomes dominant when the nanometer size range is reached. Additionally, a number of physical properties change when compared to macroscopic systems. One example is the increase in surface area to volume of materials. This catalytic activity also opens potential risks in their interaction with biomaterials.
Additionally, materials reduced to the nanoscale can suddenly show very different properties compared to what they exhibit on a macroscale, enabling unique applications. For instance, opaque substances become transparent (copper); inert materials become catalysts (platinum); stable materials turn combustible (aluminum); solids turn into liquids at room temperature (gold); insulators become conductors (silicon) to name a few.
Additionally, nanosize powder particles are important for the achievement of uniform nanoporosity and similar applications. However, the tendency of small particles to form clumps (“agglomerates”) is a serious technological problem that impedes such applications.
Another deficiency is that the volume of an object decreases as the third power of its linear dimensions, but the surface area only decreases as its second power. This somewhat subtle and unavoidable principle has huge ramifications. For example the power of a drill (or any other machine) is proportional to the volume, while the friction of the drill's bearings and gears is proportional to their surface area. For a normal-sized drill, the power of the device is enough to handily overcome any friction. However, scaling its length down by a factor of 1000, for example, decreases its power by 10003 (a factor of a billion) while reducing the friction by only 10002 (a factor of “only” a million). Proportionally it has 1000 times less power per unit friction than the original drill. If the original friction-to-power ratio was, say, 1%, that implies the smaller drill will have 10 times as much friction as power. The drill is useless.
This is why, while super-miniature electronic integrated circuits can be made to function, the same technology cannot be used to make functional mechanical devices in miniature.
Nanomaterials from a “bottom-up” design also have certain deficiencies which must be assessed. Modem synthetic chemistry has reached the point where it is possible to prepare small molecules to almost any structure. These methods are used today to produce a wide variety of useful chemicals such as pharmaceuticals or commercial polymers. However, the ability of this to extend into supramolecular assemblies consisting of many molecules arranged in a well defined manner is problematic. Such bottom-up approaches should, broadly speaking, be able to produce devices in parallel and much cheaper than top-down methods. However, most useful structures require complex and thermodynamically unlikely arrangements of atoms. The basic laws of probability and entropy make it very unlikely that atoms will “self-assemble” in useful configurations, or can be easily and economically nudged to do so. About the only example of this is crystal-growing, for which Nanotechnology cannot take any credit.
Given the deficiencies associated with “top-down” and “bottom-up” nanomaterials, it becomes clear that providing a functional approach to nanotechnology (i.e. the development of nanomaterials of a desired functionality) can be problematic. Finally, implementing nanotechnologies in highly-regulated bulk manufacturing applications, such as pharmaceutical manufacturing, only compounds problems. The present invention overcomes these problems.